FDA Issues Final Ag Water Rule, IFPA Reacts

May 6, 2024

Washington, DC – In response to today’s publication release of the U.S. Food and Drug Administration’s final rule on agricultural water, the International Fresh Produce Association is pleased to see feedback the organization and its volunteers provided to the agency incorporated into the regulation.

“Since its introduction in 2015 as a subpart of the FSMA Produce Safety Rule, our industry has been working with FDA to enhance the original agricultural water regulation so it is easier to understand and implement,” said IFPA Chief Food Safety & Regulatory Officer Natalie Dyenson. “Much progress has been made from the original proposal, which was overly complex, one-size-fits-all, and didn’t allow for flexibility considering existing scientific limitations. This final rule highlights FDA’s willingness to incorporate stakeholder feedback and ultimately put forth a rule that protects public health.”

In 2022, FDA issued a new pre-harvest agricultural water rule and held public meetings to solicit public comment on the proposed changes to the rule. IFPA responded with testimony from the organization’s Vice President of Regulatory Compliance & Global Food Safety Standards Dr. Emily Moyer which called for regulations with flexibility that allow fruit and vegetable growers to manage risks unique to their production environments.

“A vast majority of fresh produce growers are already managing their ag water risks as a response to buyer or third-party audit requirements. Now, we finally have a set rule that federally regulates pre-harvest ag water,” Moyer commented.

In its announcement, the FDA stated the revised requirements to the rule are intended to enhance public health by improving the safety of water used in produce cultivation and are designed to be practical across various agricultural water systems, uses, and practices, while remaining adaptable to future advancements in agricultural water quality science. Specifically, the rule:

Establishes requirements for agricultural water assessments that evaluate a variety of factors that are key determinants of contamination risks associated with pre-harvest agricultural water. This includes an evaluation of the water system, water use practices, crop characteristics, environmental conditions, potential impacts on water from adjacent and nearby land, and other relevant factors.
Includes testing pre-harvest agricultural water as part of an assessment in certain circumstances.
Requires farms to implement effective mitigation measures within specific timeframes based on findings from their assessments. Hazards related to certain activities associated with adjacent and nearby land uses are subject to expedited mitigation.
Adds new options for mitigation measures, providing farms with additional flexibility in responding to findings from their pre-harvest agricultural water assessments.

Volunteer members of the IFPA Food Safety Council have been focused on the agricultural water rule as one of their priorities. In 2023, a subset of the Council created guidance materials (shared with FDA) to help industry prepare for compliance with the then-proposed regulation’s requirements, address commonly found uncertainties with the rule, and provide additional resources for the produce industry.

One such IFPA resource is Water Treatment: The Label is the Law, an analysis that focuses on the legalities of treating agricultural water, which applies to pre-harvest, harvest, and post-harvest water uses.

“One of our Council’s biggest concerns was the potential for a final rule that did not align with how the produce industry operates every day, which is why they were intent on providing thoughtful and insightful guidance,” said Dyenson. “Seeing their expertise reflected in the spirit of the final rule is a great illustration of the power of collaboration between industry and regulators to ensure rules are both realistic and workable.”

FDA Issues Final Ag Water Rule, IFPA Reacts

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